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Repatha

Generic name: evolocumab [E-voe-LOK-ue-mab]
Drug class: PCSK9 inhibitors

What is Repatha?

Repatha, a human monoclonal antigen, is used to treat a variety of diseases. It helps the liver reduce "bad" levels of cholesterol (low-density lipoprotein, or LDL).Repatha can be used in conjunction with a low-fat diet and other medications to lower cholesterol levels for people who have homozygous or heterozygous familial high cholesterol (inherited forms of it). These conditions can lead to high levels of LDL (bad) cholesterol in the blood as well as plaque buildup inside your arteries.Repatha can also be used to lower the risk of stroke or heart attacks in patients with heart problems or blood vessel issues caused by plaque or hardening of the arteries.

Side effects of Repatha

If you experience any of the following symptoms of an allergic reaction: hives; severe itching; difficulty breathing; swelling in your face, lips, or throat;

If you experience:

  • High blood sugar: increased thirst, increased urination, and a fruity breath smell.

Repatha may cause side effects such as:

  • Redness, pain or bruises at the injection site
  • Back pain
  • Flu symptoms
  • Cold symptoms include a stuffy nose, sneezing, and a sore throat.

There may be other side effects. Call your doctor for medical advice about side effects.The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Warnings

You should read the entire label and package instructions before taking your medicine. Tell your doctor about any medical conditions you may have, allergies and medications that you take.

Before you take this drug

Repatha should not be used if you have an allergy to evolocumab.

Tell your doctor about any of the following to ensure that Repatha will be safe for you:

  • Liver or kidney disease
  • A latex allergy.

You may find your name on a registry for pregnant women to monitor the effects of the drug on the child.Breastfeeding may not be possible while taking this medication. You should consult your doctor if you are concerned about any risks.Repatha should not be given to children without medical advice. Evolocumab cannot be used by children younger than 10 years old. Repatha is not recommended for children under 10 years old if they have certain medical conditions.

Similar/related drugs

atorvastatin, Ozempic, rosuvastatin, Xarelto, simvastatin, ezetimibe, and lipitor

How to take Repatha?

Repatha should be taken exactly as prescribed. Read all the instructions on the prescription label.Repatha can be injected directly under the skin. You may be taught how to inject at home. You should not administer this medication to yourself if you don't know how to properly use the needles or syringes.Repatha can be given twice a week or once a month. You may have to inject up to three separate doses in one go, depending on the amount of your dosage. Do not forget to follow your doctor's instructions.Repatha comes in three different forms: a prefilled syringe or autoinjector (SureClick) or an on-body infusor (Pushtronex) with a cartridge prefilled. You should read all the information provided, including medication guides and instructions. If you have questions about the injection device that was prescribed to you, ask your doctor or pharmacist. You can also call the manufacturer directly at 1-844-737-2842.This medicine can be injected in as little as 15 seconds using a SureClick autoinjector or a prefilled syringe. You should finish your injections in 30 minutes if you are using more than one at a given time.Pushtronex is a hands-free, special device that can be placed on your skin to deliver your evolocumab slowly. Please read and follow the instructions carefully. Wear the device for approximately 9 minutes in order to receive the full dosage. You can walk, bend, and reach while wearing the on-body infusor.Your healthcare provider will show you the best spots on your body where you can inject Repatha or place the on-body infusor. Each time you inject, use a new location. Don't inject in the same spot twice.

Each prefilled single-use syringe or cartridge is only intended for one use. Even if some medicine is left in the syringe, throw it away after use. Use syringes and needles in accordance with any local or state laws. Ask your pharmacist how to dispose of a "sharps container" that is puncture-proof. This container should be kept out of the reach of pets and children.Repatha should be stored in its original packaging in the fridge, away from heat and light. Do not freeze. Do not freeze any medicines.Before injecting, remove the medicine from the refrigerator. Allow it to come to room temperature between 30 and 45 minutes. Never heat an injection device or syringe.Repatha can be stored in its original carton at room temperature and away from heat and light. If the medicine is stored at room temperature, it should be used within 30 days.Handle this medication with care. A broken injection device may result from dropping it. Even if there is no visible break, do not use an injectable device that you have dropped on a hard surface. For new medication, call your pharmacist.

This medicine should not be shaken. If the color of your medicine has changed or if it has particles, do not use it. For new medication, call your pharmacist.Do not stop taking Repatha without consulting your doctor, as your LDL cholesterol level may rise.Repatha is part of an overall treatment plan that includes statin medications, a diet, and regular blood tests. You should follow your doctor's advice.

Details on dosage

Adult dose for hyperlipidemia:

Subcutaneously, 140 mg every 2 weeks or 420 mg once a month
Comments:
When clinically indicated, the effect of LDL-C lowering can be measured as soon as four weeks after starting treatment.
LDL-C levels should be checked just before the next dose for patients who receive 420 mg per month.
When switching dose regimens, give the first dose on the scheduled date for the prior regimen.
Uses:
in adults who have established cardiovascular disease, to reduce the risk for myocardial ischemia, stroke, and coronary revascularization.
As an adjunct to diet alone or combined with other LDL-lowering therapies to treat primary hyperlipidemia, including heterozygous family hypercholesterolemia.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia:

Subcutaneously, 140 mg every 2 weeks or 420 mg once a month
Comments:
When clinically indicated, the effect of LDL-C lowering can be measured as soon as four weeks after starting treatment.
LDL-C levels should be checked just before the next dose for patients who receive 420 mg per month.
When switching dose regimens, give the first dose on the scheduled date for the prior regimen.
Uses:
in adults who have established cardiovascular disease, to reduce the risk for myocardial ischemia, stroke, and coronary revascularization.
As an adjunct to diet alone or combined with other LDL-C-lowering treatments for primary hyperlipidemia, including heterozygous family hypercholesterolemia.

Usual Adult Dose for Cardiovascular Risk Reduction:

Subcutaneously, 140 mg every 2 weeks or 420 mg once a month
Comments:
When clinically indicated, the effect of LDL-C lowering can be measured as soon as four weeks after starting treatment.
LDL-C levels should be checked just before the next dose for patients who receive 420 mg per month.
When switching dose regimens, give the first dose on the scheduled date for the prior regimen.
Uses:
in adults who have established cardiovascular disease, to reduce the risk for myocardial ischemia, stroke, and coronary revascularization.
As an adjunct to diet alone or combined with other LDL-C-lowering treatments for primary hyperlipidemia, including heterozygous family hypercholesterolemia.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: subcutaneously, 420 mg once a month.
If clinically meaningful responses are not seen in 12 weeks, the dose may be increased to 420 mg every 2 weeks.
Concomitant use with lipid apheresis
Patients undergoing lipid apheresis can begin treatment by administering 420 mg subcutaneously every two weeks. This dose should correspond to their apheresis regimen.
Comments:
When clinically indicated, the effect of LDL-C lowering can be measured as soon as four weeks after starting treatment.
LDL-C levels should be checked just before the next dose for patients who receive 420 mg per month.

Use: As an addition to other LDL-lowering therapies to treat homozygous familial hypercholesterolemia.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia:

If you are 10 or older,
Initial dose: subcutaneously, 420 mg once a month.
If clinically meaningful responses are not seen in 12 weeks, the dose may be increased to 420 mg every 2 weeks.
Concomitant use with lipid apheresis
Patients undergoing lipid apheresis can begin treatment by administering 420 mg subcutaneously every two weeks. This dose should correspond to their apheresis regimen.
Comments:
When clinically indicated, the effect of LDL-C lowering can be measured as soon as four weeks after starting treatment.
LDL-C levels should be checked just before the next dose for patients who receive 420 mg per month.
Use: Used as an adjunct to other LDL-lowering therapies for pediatric patients 10 or older to treat homozygous familial hypercholesterolemia to reduce LDL-C.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

10 years and older: 140mg subcutaneously every two weeks or 420mg subcutaneously for one month
Comments:
When clinically indicated, the effect of LDL-C lowering can be measured as soon as four weeks after starting treatment.
LDL-C levels should be checked just before the next dose for patients who receive 420 mg per month.
When switching dose regimens, give the first dose on the scheduled date for the prior regimen.
Use: To reduce LDL cholesterol in patients aged 10 or older who have HeFH.

What happens if I miss the dose?

You can use the missed dose up to 7 days after it was due. If you have missed the dose by more than seven days, skip it. If you miss a dose, follow your original schedule to use the medication again at your next scheduled dosage.Don't use extra medication to make up for a missed dosage.

What happens if I overdose?

For poison assistance, call 1-800-222-1222 or get immediate medical help.

What should be avoided?

Repatha should not be injected into skin that has been bruised, sore, scabbed, or hardened.

Interaction with other drug

Other drugs, such as prescription and over-the-counter medicines, herbal products, and vitamins, may interact with Evolocumab. Inform your healthcare providers of all medications you are taking and those you plan to take.